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Tufts University researchers studying immigrant workers in a nearby community engaged local leaders and teens to help them create a survey and recruit and translate for the immigrant population. It was an example of community-based participatory research (CBPR), involving the community from start to finish.1

But the group ran into an unexpected obstacle when the community leaders questioned the necessity of Tufts' human subjects protection requirements, says Raymond Hyatt, PhD, MS, assistant professor of public health and community medicine at Tufts University in Boston, MA.

"We thought they'd be more conservative about human subjects protections than we would be," Hyatt says. "But it was quite the opposite. The community leaders viewed the IRB process as something that seemed like university bureaucracy."

In order to explain the importance of the human subjects protections being employed in the study, Hyatt and his colleagues created their own education program for the community partners. They also enlisted the Tufts IRB administrator to answer questions from the community and explain the IRB's role.

"Our IRB leaders at Tufts are spectacular," Hyatt says. "They were willing to be involved in helping the research team do this."

As a result, Hyatt says, not only was the community partnership for this study successful, but many of the community leaders have gone on to take more formalized Collaborative IRB Training Initiative (CITI).

"Six of these people have completed CITI training and now qualify as research investigators at Tufts University, which is remarkable," he says. "These are community leaders, not academics."

Risks to participants, teen volunteers

Hyatt's group was studying occupational health risks among immigrant workers in Somerville, MA. The team, assisted by leaders from community organizations in Somerville, designed a survey of workers and enlisted teenagers, who often had experience translating for their relatives, to help recruit potential participants.

Risks to participants included the possibility that the workers could lose their jobs or be revealed as undocumented immigrants and deported.

In addition, the teenage translators (who Hyatt says were also surveyed as part of the project and thus considered to be subjects themselves) could face retaliation in the community if others thought they were collaborating with authorities.

Community partners in the study included an immigrant health service, a Latino youth organization, and Haitian and Brazilian immigrant groups. Many of the community leaders involved had previous research experience, and had done their own surveys of their community, but were not familiar with IRBs, Hyatt says.

"Even though they do surveys with their own population, they don't have an IRB because it's not research," Hyatt says. "And they had some healthy skepticism about the process."

Community leaders would make comments such as "Why does Tufts require all this bureaucracy? We survey our communities all the time and no one worries about this." They worried that the informed consent document would scare participants away.

Creating a training program

When this problem arose, Hyatt says he and his colleague, David Gute, consulted with the IRB administrator at the time, Helen Page, to determine what approach to take with the community leaders. They ended up with a three-part program to try to alleviate the concerns:

Explaining the need for protections – Hyatt and Gute put together an introductory session for the community partners about the history of human subjects protections and why they're necessary. They talked about historic cases such as the Tuskegee syphilis experiments. They also talked about their own past research projects and how the IRB process had helped them identify risks they hadn't anticipated.

Training in research design – including informed consent and how to administer surveys. Hyatt says they provided templates of consent forms, using forms from past projects.

Meeting with the IRB administrator – Hyatt says Page agreed to meet with the community leaders at one of their offices. She made a short presentation and participated in a discussion for about 90 minutes, answering their questions.

Hyatt says that meeting was a crucial part of the process.

"It demystified the IRB to the community partners, and just as importantly, demystified the community partners to the IRB," he says. "There ended up being a lot of relaxation on both their parts."

Hyatt says if he had to do the project over again, he would have started that human subjects protection education sooner.

He says the fact that several community partners have now completed CITI training will make future collaborations easier. But in the initial stages of a CBPR partnership, Hyatt says it makes sense for the research team themselves to do the introductory education in human subjects protection issues.

"An initial education with the researchers is probably best, to come to a workable understanding together," he says. "That really strengthens the research partnership."

Hyatt says this issue is likely to face other IRBs as they get proposals for community-based participatory research projects. He says IRBs can prepare for this now by becoming more conversant in CBPR issues.

"I think that IRBs could now start to do some training anticipating these kinds of protocols," he says.